Understanding Telix, page-307

The pilot prospective study of twelve (12) metastatic patients demonstrated theexpression of CAIX in TNBC and effective targeting with radiolabelled girentuximab: -- Expression and targeting of CAIX in lesions in the breast, skin, adrenal gland and brain was 100% -- Expression in nodes and bone was 88.0% and 91.9%, respectively -- TLX250-CDx was found to be safe and well tolerated by patients.


Triple Negative Breast Cancer Presented at SABCSPositive Topline Results from Phase II OPALESCENCE Study of TLX250-CDx in Triple NegativeBreast Cancer Presented at SABCS PR Newswire MELBOURNE, Australia, Dec. 6, 2023 MELBOURNE, Australia, Dec. 6, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX:TLX, Telix, the Company) announces positive topline results from the Phase II OPALESCENCEinvestigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positronemission tomography (PET) imaging candidate, TLX250-CDx ((89) Zr-DFO-girentuximab), inpatients with triple negative breast cancer (TNBC). Results will be presented today atthe 2023 San Antonio Breast Cancer Symposium(R) (SABCS). The pilot prospective study of twelve (12) metastatic patients demonstrated theexpression of CAIX in TNBC and effective targeting with radiolabelled girentuximab: -- Expression and targeting of CAIX in lesions in the breast, skin, adrenal gland and brain was 100% -- Expression in nodes and bone was 88.0% and 91.9%, respectively -- TLX250-CDx was found to be safe and well tolerated by patients. The OPALESCENCE study (ClinicalTrials.gov ID NCT04758780) was undertaken by Dr.Caroline Rousseau at the Institut de Canc?rologie de l'Ouest (ICO) in St Herblain(France). The primary objective was to evaluate how CAIX-targeted imaging with PET can beutilised for the diagnosis and staging of TNBC and to develop a deeper understanding ofCAIX as a potential therapeutic target in this patient population where there issignificant unmet medical need. Results demonstrate the ability of TLX250-CDx to detect lesions that may resistchemotherapy and have a more aggressive profile resulting from hypoxia. The theranosticpotential for girentuximab in this poor prognosis disease supports Telix's goal to expandits CAIX program into other indications beyond renal (kidney) cancer, including futureapplications for lutetium-177 ((177) Lu) and actinium-225 ((225) Ac) based therapies. Principal Investigator for the OPALESCENCE study, Dr. Caroline Rousseau stated, "We arepleased to present encouraging topline results from this study of Telix's investigationalCAIX targeting imaging agent in TNBC at SABCS, the largest and most prestigiousscientific gathering on breast cancer research worldwide. Telix's imaging agentTLX250-CDx, which has shown high sensitivity and specificity in clinical trials for thedetection of clear cell renal cell carcinoma,([1]) has now also exhibited potentialutility in this most aggressive form of breast cancer, which is often metastatic anddrug-resistant, with limited therapeutic options." Dr. Christian Behrenbruch, Managing Director and Group CEO added, "Identifying newtargets and treatment strategies for TNBC is a severe unmet need where only 20 percent ofdiagnosed patients are currently eligible for PD-L1-targeted therapies,([2]) the standardof care, with the remainder reliant on toxic chemotherapeutic regimens. This toplineimaging data may demonstrate proof of concept for future therapeutic applications ofradiolabelled girentuximab based on a "theranostic" approach. Telix looks forward tocontinuing to support the development of its CAIX-targeting antibody-based program forpatients with TNBC and other solid tumours, with the ultimate aim to establish CAIX aspan-cancer therapeutic target." About Triple Negative Breast Cancer Breast cancer is the most common cancer in women and the second most common canceroverall.([3]) In 2020, over 2.2 million women were diagnosed with breast cancer and685,000 died from their disease.([4]) Triple negative breast cancer (TNBC) accounts forabout 10-15% of all breast cancers with the term triple negative referring to the factthat the cancer cells do not have any of the three markers commonly found on breastcancer cells -- the oestrogen and progesterone receptors, and HER2 protein. TNBCs differfrom other types of invasive breast cancer in that they grow and spread faster, havelimited treatment options, and a poorer prognosis.([5]) About the Institut de Canc?rologie de l'Ouest (ICO) ICO is a 1,400 professional strong not-for-profit center fighting against cancer. Itwelcomes close to 48,000 patients per year, and conducts the mission and service of apublic hospital. Strengthened by its 4 missions -- Prevention, Care, Research andTeaching -- ICO offers broad, state-of-the-art expertise that is exclusively dedicated tocancerology. Advanced medicine at the service of patients: specialising in oncology, theICO's provides patients with personalised, innovative and multidisciplinary care at everystage of treatment. From rapid diagnosis to surgery, chemotherapy and radiotherapy, carealso extends to supportive care, which is highly developed at ICO. The integration of care, research and innovation is integral to ICO. Researchactivities, which are a specific mission at ICO, are undertaken from concept all the waythrough to clinical trials. Research is conducted in all disciplines of cancerology:medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery,support care, and human sciences. Patients who are cared for at ICO receive privilegedaccess to cutting edge clinical trials in cancerology. The mission of the Innovation Unitis to support innovation in oncology by assisting both internal and external projectleaders from the initial idea to the operational implementation of the innovation. Through its teaching mission and academic expertise, ICO contributes to the training oftomorrow's cancer professionals. For more information contact[email protected] About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisationof diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telixis headquartered in Melbourne, Australia with international operations in the UnitedStates, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio ofclinical-stage products that aims to address significant unmet medical needs in oncologyand rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of thelatest share price, announcements made to the ASX, investor and analyst presentations,news releases, event details and other publications that may be of interest. You can alsofollow Telix on LinkedIn. TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix's leadimaging product, gallium-68 ((68) Ga) gozetotide injection (also known as (68) Ga PSMA-11and marketed under the brand name Illuccix(R) ), has been approved by the U.S. Food andDrug Administration (FDA),([6]) by the Australian Therapeutic Goods Administration(TGA),([7]) and by Health Canada.([8]) Telix's SENSEI(R) ultra-miniaturised robotic gamma probe is registered as a Class 1device with the FDA, and has attained a Conformit? Europ?enne (CE) Mark for use in theEuropean Economic Area for intra-operative detection of sentinel lymph nodes.([9]) Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected]